King's Test
Vanderbilt University
Department of Biomedical Engineering
Pilot Program of designsafeŽ in Academia
Summary of Experiences Fall 1998 - Spring 1999
Summary of Fall Use, BME Senior Design Class:
Two groups of 5 students were to evaluate the software and attempt to make it specific to medical uses. One group did quite a bit better than the other in that they were more practical and practice oriented. Copies of these reports have been provided.
All students were to develop the equivalent of an example for next year's class - a problem statement and an example solution. This exercise showed a very large variability in the results produced. Some students generated multiple pages for fairly simple exercises, a few generated very brief examples. The best results seem to have come from students who have had some practical experience, such as an internship in the past year or two, or who are currently working in our hospital in various clinics and research labs. Some of the better designsafeŽ reports were from students who have already started their senior design project (voice-controlled wheelchair, fetal stabilizer, laser systems, catheter design, for example). Electronic copies of all these reports have also been provided.
Summary of Spring 1999 designsafeŽ experiences.
A report of my experiences in use of designsafe was presented at the Second Annual Tennessee Conference on Biomedical Engineering. The abstract may be seen at the web address: http://www.bme.vanderbilt.edu/tnbme2/pilot_program_of_designsafe_in_b.htm, the paper essentially covered the material above. The PowerPoint slide show that was used has been provided to Mr. Bruce Main. The session that the presentation was made in was titled Biomedical Engineering Education, the session was attended by about 40 persons.
A requirement for the Spring term was that each design group (of 28) turn in a design report as well as present a poster session on their work Specifically, the report requirements included: "If applicable the results section must include a discussion of any safety issues regarding your project. Proper use of designsafeŽ will ensure this (document). In like fashion, all projects must address any ethical or societal issues relevant to your work in the recommendations section or separately. Discussion of other issues, such as human subject participation, FDA approvals, etc. must also be addressed. " A few of the final reports may be see on the web sites listed at: http://vubme.vuse.vanderbilt.edu/King/student_project_listing_1998_99.htm, the majority of the final reports containing designsafe information are only in printed form. Those students and their projects reporting use of designsafe are listed below:
Davis, Hormone Concentration Gradients, analysis of generally negligible risks to researcher & assistants in research environment.
Desai/Mani, Fetal-Stabilizing Forceps Design, brief analysis of risks to fetus from device.
Hughes/Browne/Prill, Automated Delivery of FEL -, reasonable analysis of laser risk to operators & technicians in an orthopedics application.
Pollock/Burrow/Tice, Rehabilitation Device -, analysis of "swinging bridge" design, addition of handrails to prevent injury.
Harrison/McInerny, Raman Spectroscopy, overview (reasonable) of laser and bacterial infection risks in ear infection diagnosis.
Futral/Schmid/Tandy, Rehab. Device, brief analysis of operator & user risks on a parallel bar system re-design.
Abenojar/Benson, Steerable Catheter, overkill analysis of risks to trainees, manufacturer, radiologist, & nurse assistant in the use of a new catheter. Missing is the risk to the patient!
Henbest/Sapra, Steerable Catheter, analysis of risks to trainees, radiologist, & nurse assistant in the use of a new catheter. Missing is the risk to the patient!
Pedroso, Heart Assist Device, 17 page analysis of the risk to all involved in the implantation of a heart assist device. This is on the web at: http://vubme.vuse.vanderbilt.edu/pedrospd/Safty.htm, and is quite complete. Perhaps a good teaching example.
The above nine papers represent all but one of the papers that qualified in my opinion for a designsafe analysis (of 28 projects.) The one group that should have done a report was downgraded. Copies of the relevant sections of the above papers, or of the entire paper, may be had upon request.
Overall Summary Statement
Safety in the senior design course in the past has been inferred - rather than approached as a specific topic as per this year. With the designsafeŽ software package, it will be a formal part of the course structure in the future.
With my own experience in using the software and seeing the large variety of responses to my exercises, I should be in a much better position next year to give concrete examples of the use of the software, and my expectations regarding student performance. A few of the students this year did a good job, some did excellent work. I hope that a larger percentage fall in this category next year.
The one presentation I gave this year went well. I may make a second at one of my professional seminars next year, perhaps AAMI. I would like further to arrange for demonstration software to use in an invited short course at UCLA on design in early 2000.
I am happy to have had the chance to be a "beta" tester for the college scene. I plan to continue to use the software, I thank you again for the grant of this software.
Paul H. King, PhD, PE
Assoc. Prof. BME, ME, & Anesthesiology, Vanderbilt University
Phone 615-322-2201 FAX 615-343-7919
12 May 1999